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Claims and Abstract availability

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English Abstract

A miniaturized obstruction treatment device, e.g., aresilient brush, particularly adapted for medical use formedat the distal end of an elongated brush drive shaft having ahollow lumen formed therein for introduction over aguidewire. The brush drive shaft is enclosed in the lumenof a brush delivery catheter, and the brush is adapted to begaraged in a distal end section of the brush deliverycatheter lumen. A Y-connector and a brush sub-assemblyconnector are attached to the proximal end of the brushdelivery catheter and form a brush sub-assembly with thebrush drive shaft and brush. The Y-connector allowsinfusion of thrombolytic agents into the brush deliverycatheter lumen for emission at the distal end openingthereof adjacent the brush. In use, the brush sub-assemblyconnector connects the brush sub-assembly with a drive motorunit connector of a drive motor unit. The drive motor unitreceives the proximal end of the drive shaft and rotates itto rotate the brush bristles. The brush and brush driveshaft distal section are automatically extended out of thecatheter lumen distal end opening when the sub-assemblyconnector and the drive motor unit connector positively locktogether. Simultaneously, a drive hub of the brush driveshaft locks into a drive chuck of a drive motor unit toenable rotation of the drive shaft, and the drive shaftproximal end is seated in a dynamic seal that inhibitsinfiltration of blood and thrombolytic agent into the drivemotor housing.

Note: Claims are shown in the official language in which they were submitted.

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CLAIMS:

1. A motor and brush assembly preferably for use in amedical procedure at a site within a patient's bodycomprising:a brush sub-assembly comprising:an elongated, flexible, rotatable brush drive shaftextending between a proximal drive shaft end and a distaldrive shaft end;a brush formed in a distal portion of the brushdrive shaft;a proximal drive member formed in a proximal portionof said brush drive shaft;an elongated, flexible, brush delivery catheterextending between a proximal catheter end and a distalcatheter end and formed with a catheter lumen extendingbetween proximal and distal catheter lumen end openingsat the proximal and distal catheter ends;fitting means for fitting a distal drive shaftsection of said brush drive shaft within said catheterlumen and for extending said proximal drive memberproximally of said proximal catheter lumen end openingfor allowing rotation of said brush drive shaft withrespect to said brush delivery catheter; anda brush sub-assembly connector having a proximalseat extending proximally from said fitting means throughwhich said proximal drive member extends proximally; anda drive motor unit adapted to be coupled with saidbrush sub-assembly to effect rotation of said brush driveshaft further comprising:a drive motor housing containing a drive motor lumenextending between drive motor lumen proximal and distal

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end openings in said drive motor housing, said drivemotor lumen dimensioned to receive said proximal drivemember;drive means located within said drive motor housingfor engaging said proximal drive member when it isinserted through said distal drive motor lumen endopening and into said drive motor lumen and for rotatingsaid drive shaft; anda drive motor unit connector having a drive motorunit receptacle for engaging said brush sub-assemblyproximal seat as said proximal drive member is advancedproximally through said distal drive motor lumen endopening and into said drive motor lumen to seat saidproximal drive member in said drive motor lumen andretain said proximal drive member in engagement with saiddrive means located within said drive motor housing, saiddrive motor unit connector and said brush sub-assemblyconnector cooperatively allowing slidable rotation ofsaid proximal seat with respect to said drive motor unitreceptacle to a selected angular alignment of said brushsub-assembly to said drive motor unit while maintainingsaid proximal drive member seated in said drive motorlumen and in engagement with said drive means.2. The assembly of Claim 1, wherein:said fitting means of said brush sub-assembly furthercomprises an adaptor having an adaptor body axially alignedwith said brush delivery catheter and enclosing an adaptorlumen aligned axially with said catheter lumen and coupledwith said proximal catheter lumen end opening having and aside port extending laterally to the adaptor body and theaxial direction of said brush drive shaft having a side port

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lumen for coupling with a source of diagnostic ortherapeutic agent for introduction of such diagnostic ortherapeutic agent into said brush delivery catheter lumenfor transmission through said catheter lumen alongside saiddistal drive shaft section within said catheter lumen andemission from said catheter lumen distal end opening; andsaid drive motor unit connector and said brush sub-assembly allow rotation of said brush sub-assembly withrespect to said drive motor unit to any selected angularalignment to accommodate the direction that the side portextends when coupled with the source of diagnostic ortherapeutic agent.3. The assembly of Claim 2, wherein:said drive means further comprises a drive motor andpower supply coupled to said drive motor through a switchthat is manually engageable while said drive motor housingis manipulated to rotate said brush drive shaft; andsaid drive motor unit connector and said brush sub-assembly allow rotation of said brush sub-assembly withrespect to said drive motor unit to any selected angularalignment to accommodate the direction that the side portextends when coupled with the source of diagnostic ortherapeutic agent and to enable the manipulation of themotor drive housing and operation of the switch.

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4. The assembly of Claim 3, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor unit receptacle to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid brush sub-assembly connector comprises a clipconnector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said brush sub-assembly connector with said drive motor unit connector;anda moment arm joined by a resilient hinge to the clipconnector barrel extending outward of the clip connectorbarrel, the moment arm extending proximally from saidresilient hinge alongside said proximal drive member to afree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening andproximal advancement of said proximal drive member

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through said drive motor lumen brings said free clip endinto contact with said camming surface to bias said freeclip end radially away from said proximal drive memberagainst said resilient hinge until said free clip endengages said annular retention groove and said proximalseat is seated within said drive motor lumen distal endopening, whereupon said brush sub-assembly and said drivemotor unit can be rotated with respect to one another assaid free clip end traverses and is retained in saidannular retention groove.5. The assembly of Claim 4, wherein said clipconnector further comprises:a finger grip formed in a distal extension of saidmoment arm extending distally from said resilient hingealongside said barrel, whereby said free clip end can beretracted away and released from said retention groove bydepression of said finger grip toward said barrel inorder to retract said proximal drive member from saiddrive motor lumen.6. The assembly of Claim 3, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid brush sub-assembly connector comprises a clipconnector further comprising:

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a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the Adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said brush sub-assembly connector with said drive motor unit connector;anda first moment arm joined by a first resilient hingeto the clip connector barrel at a first hinge locationextending outward of the clip connector barrel, the firstmoment arm extending proximally from said first resilienthinge alongside said proximal drive member to a firstfree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat; anda second moment arm joined by a second resilienthinge to the clip connector barrel at a second hingelocation extending outward of the clip connector barreldisposed at 180° to said first hinge location, the secondmoment arm extending proximally from said secondresilient hinge alongside said proximal drive member to asecond free clip end that is turned radially inwardtoward said proximal drive member and locatedsubstantially at said predetermined distance proximal tosaid proximal annular seat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening and

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proximal advancement of said proximal drive memberthrough said drive motor lumen brings said first andsecond free clip ends into contact with said cammingsurface to bias said first and second free clip endsradially away from said proximal drive member againstsaid first resilient hinge until said first and secondfree clip ends engage said annular retention groove andsaid proximal seat is seated within said drive motorreceptacle surrounding said drive motor lumen distal endopening, whereupon said brush sub-assembly and said drivemotor unit can be rotated with respect to one anotherthrough as said first and second free clip ends traverseand are retained in said annular retention groove.

7. The assembly of Claim 6, wherein said clipconnector further comprises:a first finger grip formed in a distal extension ofsaid first moment arm extending distally from said firstresilient hinge along one side of said barrel; anda second finger grip formed in a distal extension ofsaid second moment arm extending distally from saidsecond resilient hinge along an opposite side of saidbarrel,whereby said first and second free clip ends can beretracted away and released from said retention groove bydepression of said first and second finger grips towardsaid barrel in order to retract said proximal drivemember from said drive motor lumen.

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8. The assembly of Claim 1, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid brush sub-assembly connector comprises a clipconnector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said brush sub-assembly connector with said drive motor unit connector;anda moment arm joined by a resilient hinge to the clipconnector barrel extending outward of the clip connectorbarrel, the moment arm extending proximally from saidresilient hinge alongside said proximal drive member to afree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening andproximal advancement of said proximal drive member

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through said drive motor lumen brings said free clip endinto contact with said camming surface to bias said freeclip end radially away from said proximal drive memberagainst said resilient hinge until said free clip endengages said annular retention groove and said proximalseat is seated against said drive motor unit receptaclesurrounding said drive motor lumen distal end opening,whereupon said brush sub-assembly and said drive motorunit can be rotated with respect to one another as saidfree clip end traverses and is retained in said annularretention groove.

9. The assembly of Claim 8, wherein said clipconnector further comprises:a finger grip formed in a distal extension of saidmoment arm extending distally from said resilient hingealongside said barrel, whereby said free clip end can beretracted away and released from said retention groove bydepression of said finger grip toward said barrel inorder to retract said proximal drive member from saiddrive motor lumen.

10. The assembly of Claim 1, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid brush sub-assembly connector comprises a clipconnector further comprising:

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a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said brush sub-assembly connector with said drive motor unit connector;anda first moment arm joined by a first resilient hingeto the clip connector barrel at a first hinge locationextending outward of the clip connector barrel, the firstmoment arm extending proximally from said first resilienthinge alongside said proximal drive member to a firstfree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat; anda second moment arm joined by a second resilienthinge to the clip connector barrel at a second hingelocation extending outward of the clip connector barreldisposed at 180° to said first hinge location, the secondmoment arm extending proximally from said secondresilient hinge alongside said proximal drive member to asecond free clip end that is turned radially inwardtoward said proximal drive member and locatedsubstantially at said predetermined distance proximal tosaid proximal annular seat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening and

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proximal advancement of said proximal drive memberthrough said drive motor lumen brings said first andsecond free clip ends into contact with said cammingsurface to bias said first and second free clip endsradially away from said proximal drive member againstsaid first resilient hinge until said first and secondfree clip ends engage said annular retention groove andsaid proximal seat is seated within said drive motor unitreceptacle surrounding said drive motor lumen distal endopening, whereupon said brush sub-assembly and said drivemotor unit can be rotated with respect to one another assaid first and second free clip ends traverse and areretained in said annular retention groove.

11. The assembly of Claim 10, wherein said clipconnector further comprises:a first finger grip formed in a distal extension ofsaid first moment arm extending distally from said firstresilient hinge along one side of said barrel; anda second finger grip formed in a distal extension ofsaid second moment arm extending distally from saidsecond resilient hinge along an opposite side of saidbarrel,whereby said first and second free clip ends can beretracted away and released from said retention groove bydepression of said first and second finger grips towardsaid barrel in order to retract said proximal drivemember from said drive motor lumen.

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12. The assembly of Claim 1, wherein:said drive motor unit connector comprises first andsecond moment arms that are hinged with respect to saiddrive motor unit receptacle, said first and second momentarms extending proximally from first and second hinges tofirst and second finger grips, respectively, and extendingto first and second arcuate clips that extend inward intothe annular drive motor unit receptacle in the unstressedposition of the moment arms;said brush sub-assembly connector comprises a barrelsurrounding a barrel lumen terminating in an enlargedannular proximal seat formed with a distal rim adapted to beengaged by said first and second arcuate clips when saidproximal seat is received within said annular receptacle,whereby said first and second finger grips are adaptedto be depressed inward toward the drive motor unit housingto move the arcuate clips outward so that the annularproximal seat can be inserted into the annular proximallyextending receptacle and said first and second arcuate clipsengage the distal rim on release of the tension applied tosaid first and second finger grips.

13. The assembly of Claim 12, wherein said drive motorunit connector further comprises a resilient O-ring insertedwithin the annular proximally extending receptacle toprovide a resilient seating engagement with the annularproximal seat of the barrel so that the arcuate clips forcethe annular proximal seat against the O-ring to compress itslightly, and the compressed O-ring tensions the attachmentbetween the arcuate clips and the distal rim.

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14. A motor and obstruction treatment device assemblypreferably for use in a medical procedure at a site within apatient's body comprising:an obstruction treatment device sub-assemblycomprising:an elongated, flexible, rotatable obstructiontreatment device drive shaft extending between a proximaldrive shaft end and a distal drive shaft end;an obstruction treatment device formed in a distalportion of the obstruction treatment device drive shaft;a proximal drive member formed in a proximal portionof said obstruction treatment device drive shaft;an elongated, flexible, obstruction treatment devicedelivery catheter extending between a proximal catheterend and a distal catheter end and formed with a catheterlumen extending between proximal and distal catheterlumen end openings at the proximal and distal catheterends;fitting means for fitting a distal drive shaftsection of said obstruction treatment device drive shaftwithin said catheter lumen and for extending saidproximal drive member proximally of said proximalcatheter lumen end opening for allowing rotation of saidobstruction treatment device drive shaft with respect tosaid obstruction treatment device delivery catheter; andan obstruction treatment device sub-assemblyconnector having a proximal seat extending proximallyfrom said fitting means through which said proximal drivemember extends proximally; anda drive motor unit adapted to be coupled with saidobstruction treatment device sub-assembly to effect rotation

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of said obstruction treatment device drive shaft furthercomprising:a drive motor housing containing a drive motor lumenextending between drive motor lumen proximal and distalend openings in said drive motor housing, said drivemotor lumen dimensioned to receive said proximal drivemember;drive means located within said drive motor housingfor engaging said proximal drive member when it isinserted through said distal drive motor lumen endopening and into said drive motor lumen and for rotatingsaid drive shaft; anda drive motor unit connector having a drive motorunit receptacle for engaging said obstruction treatmentdevice sub-assembly proximal seat as said proximal drivemember is advanced proximally through said distal drivemotor lumen end opening and into said drive motor lumento seat said proximal drive member in said drive motorlumen and retain said proximal drive member in engagementwith said drive means located within said drive motorhousing, said drive motor unit connector and saidobstruction treatment device sub-assembly connectorcooperatively allowing slidable rotation of said proximalseat with respect to said drive motor unit receptacle toa selected angular alignment of said obstructiontreatment device sub-assembly to said drive motor unitwhile maintaining said proximal drive member seated insaid drive motor lumen and in engagement with said drivemeans.

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15. The assembly of Claim 14, wherein:said fitting means of said obstruction treatment devicesub-assembly further comprises an adaptor having an adaptorbody axially aligned with said obstruction treatment devicedelivery catheter and enclosing an adaptor lumen alignedaxially with said catheter lumen and coupled with saidproximal catheter lumen end opening having and a side portextending laterally to the adaptor body and the axialdirection of said obstruction treatment device drive shafthaving a side port lumen for coupling with a source ofdiagnostic or therapeutic agent for introduction of suchdiagnostic or therapeutic agent into said obstructiontreatment device delivery catheter lumen for transmissionthrough said catheter lumen alongside said distal driveshaft section within said catheter lumen and emission fromsaid catheter lumen distal end opening; andsaid drive motor unit connector and said obstructiontreatment device sub-assembly allow rotation of saidobstruction treatment device sub-assembly with respect tosaid drive motor unit to any selected angular alignment toaccommodate the direction that the side port extends whencoupled with the source of diagnostic or therapeutic agent.

16. The assembly of Claim 15, wherein:said drive means further comprises a drive motor andpower supply coupled to said drive motor through a switchthat is manually engageable while said drive motor housingis manipulated to rotate said obstruction treatment devicedrive shaft; andsaid drive motor unit connector and said obstructiontreatment device sub-assembly allow rotation of saidobstruction treatment device sub-assembly with respect to

-55-~said drive motor unit to any selected angular alignment toaccommodate the direction that the side port extends whencoupled with the source of diagnostic or therapeutic agentand to enable the manipulation of the motor drive housingand operation of the switch.

17. The assembly of Claim 16, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor unit receptacle to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid obstruction treatment device sub-assemblyconnector comprises a clip connector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said obstructiontreatment device sub-assembly connector with said drivemotor unit connector; anda moment arm joined by a resilient hinge to the clipconnector barrel extending outward of the clip connectorbarrel, the moment arm extending proximally from saidresilient hinge alongside said proximal drive member to afree clip end that is turned radially inward toward said

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proximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening andproximal advancement of said proximal drive memberthrough said drive motor lumen brings said free clip endinto contact with said camming surface to bias said freeclip end radially away from said proximal drive memberagainst said resilient hinge until said free clip endengages said annular retention groove and said proximalseat is seated within said drive motor lumen distal endopening, whereupon said obstruction treatment device sub-assembly and said drive motor unit can be rotated withrespect to one another as said free clip end traversesand is retained in said annular retention groove.

18. The assembly of Claim 17, wherein said clipconnector further comprises:a finger grip formed in a distal extension of saidmoment arm extending distally from said resilient hingealongside said barrel, whereby said free clip end can beretracted away and released from said retention groove bydepression of said finger grip toward said barrel inorder to retract said proximal drive member from saiddrive motor lumen.

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19. The assembly of Claim 16, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid obstruction treatment device sub-assemblyconnector comprises a clip connector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the Adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said obstructiontreatment device sub-assembly connector with said drivemotor unit connector; anda first moment arm joined by a first resilient hingeto the clip connector barrel at a first hinge locationextending outward of the clip connector barrel, the firstmoment arm extending proximally from said first resilienthinge alongside said proximal drive member to a firstfree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat; anda second moment arm joined by a second resilienthinge to the clip connector barrel at a second hinge

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location extending outward of the clip connector barreldisposed at 180° to said first hinge location, the secondmoment arm extending proximally from said secondresilient hinge alongside said proximal drive member to asecond free clip end that is turned radially inwardtoward said proximal drive member and locatedsubstantially at said predetermined distance proximal tosaid proximal annular seat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end~opening andproximal advancement of said proximal drive memberthrough said drive motor lumen brings said first andsecond free clip ends into contact with said cammingsurface to bias said first and second free clip endsradially away from said proximal drive member againstsaid first resilient hinge until said first and secondfree clip ends engage said annular retention groove andsaid proximal seat is seated within said drive motorreceptacle surrounding said drive motor lumen distal endopening, whereupon said obstruction treatment device sub-assembly and said drive motor unit can be rotated withrespect to one another through as said first and secondfree clip ends traverse and are retained in said annularretention groove.

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20. The assembly of Claim 19, wherein said clipconnector further comprises:a first finger grip formed in a distal extension ofsaid first moment arm extending distally from said firstresilient hinge along one side of said barrel; anda second finger grip formed in a distal extension ofsaid second moment arm extending distally from saidsecond resilient hinge along an opposite side of saidbarrel,whereby said first and second free clip ends can beretracted away and released from said retention groove bydepression of said first and second finger grips towardsaid barrel in order to retract said proximal drivemember from said drive motor lumen.

21. The assembly of Claim 14, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid obstruction treatment device sub-assemblyconnector comprises a clip connector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seat

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and adapted to be aligned to said drive motor lumendistal end opening upon attachment of said obstructiontreatment device sub-assembly connector with said drivemotor unit connector; anda moment arm joined by a resilient hinge to the clipconnector barrel extending outward of the clip connectorbarrel, the moment arm extending proximally from saidresilient hinge alongside said proximal drive member to afree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening andproximal advancement of said proximal drive memberthrough said drive motor lumen brings said free clip endinto contact with said camming surface to bias said freeclip end radially away from said proximal drive memberagainst said resilient hinge until said free clip endengages said annular retention groove and said proximalseat is seated against said drive motor unit receptaclesurrounding said drive motor lumen distal end opening,whereupon said obstruction treatment device sub-assemblyand said drive motor unit can be rotated with respect toone another as said free clip end traverses and isretained in said annular retention groove.

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22. The assembly of Claim 21, wherein said clipconnector further comprises:a finger grip formed in a distal extension of saidmoment arm extending distally from said resilient hingealongside said barrel, whereby said free clip end can beretracted away and released from said retention groove bydepression of said finger grip toward said barrel inorder to retract said proximal drive member from saiddrive motor lumen.

23. The assembly of Claim 14, wherein:said drive motor unit connector is formed in said drivemotor unit housing in relation to said drive motor lumendistal end opening with a camming surface extending awayfrom said drive motor lumen distal end opening to an annularretention groove in said drive motor unit housing located apredetermined distance proximally from said drive motorlumen distal end opening; andsaid obstruction treatment device sub-assemblyconnector comprises a clip connector further comprising:a clip connector barrel enclosing a clip connectorlumen that is axially aligned to the adaptor lumen, theclip connector lumen receiving an intermediate driveshaft section of said drive shaft intermediate saidproximal drive member and said distal drive shaftsection, said clip connector lumen extending to aproximal end opening thereof within said proximal seatand adapted to be aligned to said drive motor lumendistal end opening upon attachment of said obstructiontreatment device sub-assembly connector with said drivemotor unit connector; and

-62-a first moment arm joined by a first resilient hingeto the clip connector barrel at a first hinge locationextending outward of the clip connector barrel, the firstmoment arm extending proximally from said first resilienthinge alongside said proximal drive member to a firstfree clip end that is turned radially inward toward saidproximal drive member and located substantially at saidpredetermined distance proximal to said proximal annularseat; anda second moment arm joined by a second resilienthinge to the clip connector barrel at a second hingelocation extending outward of the clip connector barreldisposed at 180° to said first hinge location, the secondmoment arm extending proximally from said secondresilient hinge alongside said proximal drive member to asecond free clip end that is turned radially inwardtoward said proximal drive member and locatedsubstantially at said predetermined distance proximal tosaid proximal annular seat,whereby insertion of said proximal drive shaft endthrough said drive motor lumen distal end opening andproximal advancement of said proximal drive memberthrough said drive motor lumen brings said first andsecond free clip ends into contact with said cammingsurface to bias said first and second free clip endsradially away from said proximal drive member againstsaid first resilient hinge until said first and secondfree clip ends engage said annular retention groove andsaid proximal seat is seated within said drive motor unitreceptacle surrounding said drive motor lumen distal endopening, whereupon said obstruction treatment device sub-assembly and said drive motor unit can be rotated with

-63-respect to one another as said first and second free clipends traverse and are retained in said annular retentiongroove.24. The assembly of Claim 23, wherein said clipconnector further comprises:a first finger grip formed in a distal extension ofsaid first moment arm extending distally from said firstresilient hinge along one side of said barrel; anda second finger grip formed in a distal extension ofsaid second moment arm extending distally from saidsecond resilient hinge along an opposite side of saidbarrel,whereby said first and second free clip ends can beretracted away and released from said retention groove bydepression of said first and second finger grips towardsaid barrel in order to retract said proximal drivemember from said drive motor lumen.25. The assembly of Claim 14, wherein:said drive motor unit connector comprises first andsecond moment arms that are hinged with respect to saiddrive motor unit receptacle, said first and second momentarms extending proximally from first and second hinges tofirst and second finger grips, respectively, and extendingto first and second arcuate clips that extend inward intothe annular drive motor unit receptacle in the unstressedposition of the moment arms;said obstruction treatment device sub-assemblyconnector comprises a barrel surrounding a barrel lumenterminating in an enlarged annular proximal seat formed witha distal rim adapted to be engaged by said first and second

-64-arcuate clips when said proximal seat is received withinsaid annular receptacle,whereby said first and second finger grips are adaptedto be depressed inward toward the drive motor unit housingto move the arcuate clips outward so that the annularproximal seat can be inserted into the annular proximallyextending receptacle and said first and second arcuate clipsengage the distal rim on release of the tension applied tosaid first and second finger grips.26. The assembly of Claim 25, wherein said drive motorunit connector further comprises a resilient O-ring insertedwithin the annular proximally extending receptacle toprovide a resilient seating engagement with the annularproximal seat of the barrel so that the arcuate clips forcethe annular proximal seat against the O-ring to compress itslightly, and the compressed O-ring tensions the attachmentbetween the arcuate clips and the distal rim.

Note: Descriptions are shown in the official language in which they were submitted.

CA 02256132 1998-12-169135400.APP PATENT-1- ROTATABLE ATTACHMENT MECHANISM FOR ATTACHING A MEDICAL OBSTRUCTION TREATMENT DEVICE SUB-ASSEMBLY TO A DRIVE MOTOR UNIT CROSS-REFERENCE TO RELATED APPLICATIONS Reference is hereby made to commonly assigned, copending U.S. Patent Application Serial Nos. (9135390. APP)filed on even date herewith for MINIATURIZED MEDICAL BRUSHin the names of Richard R. Monetti et al. and (9135410. APPfiled on even date herewith for ROTATABLE DYNAMIC SEAL AND GUIDE FOR A MEDICAL OBSTRUCTION TREATMENT DEVICE SUB- ASSEMBLY COUPLED TO A DRIVE MOTOR UNIT in the names of Blair D. Walker et al. BACKGROUND OF THE INVENTION Field of the Invention--The present invention relates toattachment of a drive motor unit to a medical obstructiontreatment device sub-assembly, and more particularly to arotatable attachment mechanism for attaching a medical brushsub-assembly comprising a brush at the distal end of a brushdrive shaft and enclosed within a brush delivery catheter,to a drive motor unit. - Description of the Background Art--Commonly assigned, U.S. Patent No. 5,370,653 to Cragg, incorporated herein byreference in its entirety, discloses a thrombectomy systemfor dissolving a soft fibrinous obstruction, such as arecently formed thrombus, within a patient's vascularsystem, either in a patent vein or artery or in a vascularimplant, e.g. an A/V graft. The thrombectomy system employsrotating brush bristles within the thrombus to separate thefibrin of the thrombus from blood cells while mixing the

CA 02256132 1998-12-169135400.APP PATENT-2-- separated fibrin with a dissolving or thrombolytic agent,e.g. streptokinase or urokinase, that is introduced at thesame time into the separated fibrin. Commonly assigned U.S. Patent No. 5,681,355 to Serra etal., incorporated herein by reference in its entirety,discloses a hollow lumen, thrombectomy brush and method offabrication which allows for the brush to be introduced overa previously placed guidewire into a very small bloodvessel. The miniaturized brush is provided with anelongated, flexible, rotatable brush or drive shaft adaptedto be attached at its proximal end to a drive motor forrotating the shaft. The drive shaft is formed with aproximal elongated section formed of a hollow, thin walltube having an inner lumen and an outer surface and a distalsection. The brush is formed of brush filaments, eachhaving first and second ends and a predetermined lengthbetween the first and second ends, entrapped in a windinginterface between turns of the coiled wire and the outerwall of the hollow tube extension in an entrapment zoneintermediate the first and second ends. The inventive rotating brush described in the '653patent has flexible brush bristles extending outward from abrush shaft or drive shaft distal end in all directions. The brush is attached to the elongated, flexible, rotatabledrive shaft or brush shaft which is attached at its proximalend to a drive motor to impart rotary motion to the brushshaft and bristles. The system includes a brush deliverycatheter adapted to be introduced and advanced through apatient's blood vessels until the distal end is positionedadjacent the soft fibrinous thrombus. Once the brushdelivery catheter is positioned, the brush bristles andbrush shaft are passed through the brush delivery catheter

CA 02256132 1998-12-169135400.APP PATENT-3-lumen and out its distal opening to place the brush incontact with the soft thrombus. The bristles aresufficiently resilient and dimensioned for allowingcompression and passage out of and back into the distalopening of the brush delivery lumen and for mixing into andmacerating the fibrin of the soft thrombus, without damaginga vessel wall. In one embodiment described in the '653 patent, thebrush shaft is hollow to define a brush shaft lumen andpreferably is formed with a penetrable distal tip valvenormally closing the distal end opening of the brush shaftlumen. The thrombolytic agent is optionally deliveredthrough the brush shaft lumen and through side exit holes orports into the region of the brush bristles. The brushshaft lumen allows the advancement of the brush over apreviously introduced and positioned guidewire to a thrombusin a blood vessel or the lumen of a medical implant. In another embodiment disclosed in the '653 patent, thebrush drive shaft is solid, and the dissolving agent isintroduced through the brush delivery catheter lumenalongside the drive shaft lumen while the brush drive shaftis rotated. The thrombolytic agent is emitted from thedistal end opening of the brush delivery catheter lumen inthe region of rotation of the brush bristles for dissolvingthe soft thrombus exposed by the rotating brush bristles. The assignee of the '653 and '355 patents and thepresent application has implemented the solid drive shaftbrush embodiment of the '653 patent in the Cragg Thrombolytic BrushT"'. The Cragg Thrombolytic BrushT"" ispresently used in the lumen of an A/V graft implanted in apatient's vascular system for hemodialysis to dissolvethrombi that form therein. The Cragg Thrombolytic BrushT""

CA 02256132 1998-12-169135400.APP PATENT' -4-_ is described and depicted in "The Thrombolytic Brush", by Andrew H Cragg, MD presented at The Second Mid-Atlantic Conference on Angio Access: Establishment and Maintenance of Dialysis and Venous Access, Williamsburg, VA (pp. 162-165 ofproceedings) in October 1996 and in product literaturepublished by the assignee in 1997. In the Cragg Thrombolytic BrushT"' embodiment, the brushand brush drive shaft are enclosed within the brush deliverycatheter as a sub-assembly that allows the brush to begaraged in the brush delivery catheter lumen as it isadvanced to the graft lumen and to be advanced out of thecatheter lumen distal end opening. The brush sub-assemblyincludes a Y-connector at the proximal end of the brushdelivery catheter that has a Y-connector lumen that thebrush drive shaft passes through. The Y-connector includesa side port coupled to an infusion port for allowingthrombolytic agent to be introduced into the Y-connectorlumen and then distally down the annular space between thebrush drive shaft and the brush delivery catheter lumen. The proximal end of the Y-connector includes a seal forsealing around the brush drive shaft to prevent leakage ofthe infused thrombolytic agent and a threaded luer connectorhaving a proximal luer hub that fits into an annular recessin the housing of the drive motor unit. An enlarged male shaft hub is formed at the proximalend of the brush drive shaft that is inserted axiallythrough a central opening of the annular recess and intoengagement with a female bore aligned with the centralopening. The female bore is integrally formed within adriven gear that is rotated by a drive gear coupled with thedrive motor. As the shaft hub is seated into the femalebore, the brush sub-assembly and the drive motor unit are

CA 02256132 1998-12-169135400.APP PATENT- -5-brought together to fit the luer hub proximal end into theannular recess of the drive motor unit. The drive motorunit and the hub are rotated with respect to one another torigidly attach them together. The brush is ejected distallyfrom the brush delivery catheter lumen. At this point, the brush delivery catheter and brushdrive shaft are extended through the patient's vascularsystem and it is undesirable to rotate them within thevascular system. It is therefore necessary to rotate thedrive motor unit while holding the brush sub-assembly stillin order the attach the luer lock elements together. It isnot always possible to know in advance just how the drivemotor unit will be aligned with respect to the side port ofthe Y-connector when the attachment is finished. Thus, theattachment process and any adjustment has to be donecarefully and relatively slowly to arrive at a suitablefinal attachment orientation. The drive motor unit is manually grasped by thephysician during the medical procedure so that the buttoncan be depressed to energize the motor and so that the motorand brush can be moved back and forth to position the brushin the graft lumen. The rigid attachment can cause the sideport of the Y-connector to extend in an awkward direction. The threaded attachment of the male and female luerconnector elements can limit the physician's ability torotate the drive motor unit and the brush sub-assembly to adesired orientation. The tubing that is coupled between theside port and the infusion port coupled with a source ofthrombolytic agent can become twisted. Moreover, the use of the luer lock attachment does notalways provide positive feedback that the attachment iscorrect which can result in imprecise longitudinal alignment

CA 02256132 1998-12-169135400.APP PATENT- -6-of the brush sub-assembly with the drive motor unit. Ifonly a few turns are engaged, the brush at the distal end ofthe brush drive shaft may be incompletely ejected from thebrush delivery catheter or the shaft hub may be incompletelyseated into the female chuck. Over tightening of the maleand female luer attachment elements can also occur. In addition, vibration of the drive motor unit when itis operated and manual twisting of drive motor unit and/orthe brush sub-assembly can cause the luer lock attachment toloosen, requiring periodic tightening or re-attachment. These problems are magnified in the context of use of ahollow lumen drive shaft that allows introduction of thebrush drive shaft over a previously positioned guidewire asenvisaged in one embodiment of the above-incorporated '653patent. In that context, it is often desirable to connectand disconnect the brush sub-assembly from the drive motorunit. At times during a procedure, it is desirable toremove or insert a guidewire from or into the proximal endopening of the drive shaft lumen while it is separated fromthe drive motor unit requiring detachment and reattachmentof the luer lock elements. A need exists for a simpler and quicker attachmentmechanism that provides repeatable and precise dimensionalattachment, positive feedback of attachment, and also allowsfor rotation of the brush sub-assembly with respect to thedrive motor unit to a convenient orientation foraccommodating infusate tubing and equipment.

CA 02256132 1998-12-169135400.APP PATENT_ _7_ SUMMARY OF THE INVENTION It is a primary object of the present invention toprovide such a simplified, repeatable, precise and positiveattachment mechanism for attaching an obstruction treatmentdevice sub-assembly with a drive motor unit. It is a principal object of the present invention toprovide such an attachment mechanism that allows full 360°rotation of the sub-assembly with respect to the drive motorunit. It is another principal object of the present inventionto provide such an attachment mechanism that is adapted toprecisely axially align an obstruction treatment devicedrive shaft with drive and sealing components of the drivemotor unit at any angular orientation of the obstructiontreatment device sub-assembly with the drive motor unit. In accordance with these and other objects, a motor andobstruction treatment device assembly is provided with arotatable, precise, positive and repeatable attachmentmechanism of the sub-assembly with the drive motor unit thatis simple to attach and separate. After attachment is made,the brush sub-assembly is rotatable to a desired angularorientation with the drive motor unit without having torelease the attachment mechanism. In accordance with the preferred embodiments of theinvention, the hand held drive motor unit is formed with adrive motor lumen for receiving a proximal drive member of abrush sub-assembly inserted into a drive motor lumen distalend opening and a drive motor unit connector. The brushsub-assembly is formed with a sub-assembly connector formaking connection with the drive motor unit connector whenthe proximal drive member is axially aligned with andinserted axially into the distal drive motor lumen opening

CA 02256132 1998-12-169135400.APP PATENT_ _8__ and seated therein. The sub-assembly connector and thedrive motor unit connector positively lock together uponaxial insertion and mutual engagement. The mutualengagement of the connectors allows rotation of the brushsub-assembly with respect to the drive motor unit to aselected angular alignment. The mutual engagement of theconnectors allows the proximal drive member to be rotated bythe drive motor unit at any selected angular alignment ofthe brush sub-assembly with respect to the drive motor unit. In one preferred embodiment, the drive motor unithousing is formed with an annular, dome shaped projectionsurrounding the drive motor unit distal end openingproviding a cam surface of increasing diameter radially fromthe axis of the drive motor unit lumen. The cam surface ismaximally bounded by an annular retention groove recessedinto the drive motor unit housing. An annular, proximallyextending, drive motor unit receptacle is formed within thedome shaped projection that also surrounds the drive motorunit distal end opening. The annular receptacle, theretention groove surrounding the annular receptacle, and thecam surface extending therebetween comprise the drive motorunit connector. The sub-assembly connector of this embodiment furthercomprises an elongated tubular barrel surrounding a sub-assembly connector lumen extending through the barrel andterminating at an enlarged annular proximal seat. A pair ofmoment arms that are hinged to the barrel and projectproximally alongside the barrel and to free clip endsthereof. The free clip ends are biased by the hinges tohave a pre-determined separation apart from one another thatis less than the diameter of the annular retention groove.

CA 02256132 1998-12-169135400.APP PATENT- -9- The attachment is effected by axially aligning theproximal seat with the annular receptacle and pressing thefree clip ends against the cam surface to cause the freeclip ends to ride upon the cam surface and to separateapart. The separation continues until the free clip endsslip into the retention groove and lock therein. The barrelcan be rotated as the free clip ends slip around theretention groove to thereby rotate the brush sub-assemblywith respect to the drive motor unit. The moment arms also extend distally from their hingesto finger grips located distal to the hinge locations. Thehinges are resilient enough to allow the finger grips to besqueezed together toward the connector barrel to increasethe separation of the free clip ends until they are releasedfrom the retention groove. In a further embodiment, the drive motor unit connectorcomprises moment arms that are hinged with respect to theannular proximally extending drive motor unit receptacle. The moment arms extend proximally from hinges to fingergrips, and extend to arcuate clips that extend inward intothe annular receptacle in the unstressed position of themoment arms. The sub-assembly connector simply comprises adistal rim of the enlarged annular proximal seat of-thebarrel. The finger grips can be depressed inward toward thedrive motor unit housing to move the arcuate clips outwardso that the annular proximal seat can be inserted into theannular proximally extending receptacle past them. Thearcuate clips engage the distal rim on release of thetension applied to the finger grips. A resilient O-ring isalso inserted within the annular proximally extendingreceptacle to provide a resilient seating engagement withthe annular proximal seat of the barrel. The arcuate clips

CA 02256132 1998-12-169135400.APP PATENT-10-force the annular proximal seat against the O-ring tocompress it slightly, and the compressed 0-ring tensions theattachment between the arcuate clips and the distal rim. In both preferred embodiments, the brush sub-assemblycomprises a brush mounted to a brush drive shaft, a brushdelivery catheter having a catheter lumen receiving thebrush drive shaft, and the sub-assembly connector. The sub-assembly connector is coupled with the proximal end of thebrush delivery catheter, preferably through an intermediate Y-connector. The sub-assembly connector lumen is alignedwith the catheter lumen, preferably through an intermediate Y-connector lumen, for receiving the brush drive shaft. Thebrush drive shaft is rotatable within the aligned lumens byoperation of the drive motor unit. The elongated, flexible, rotatable drive shaft extendsfrom a proximal drive shaft end to a distal drive shaft endand preferably is formed with a drive shaft lumen extendingthrough its length between lumen openings at the proximaland distal drive shaft ends. An elongated, flexible, distaldrive shaft section in which the brush is formed isdimensioned to fit within a catheter lumen of a brush andthrombolytic agent delivery catheter. The proximal drivemember is formed in a portion of the drive shaft proximal tothe distal drive shaft section and is configured to bereceived in a drive motor lumen of the drive motor unit. When the proximal drive member is received in and seated inthe drive motor lumen, it engages drive components of thedrive motor unit for rotating the drive shaft and brush andthe proximal drive shaft end is accessible from a proximaldrive motor lumen end opening. The proximal drive member isreceived in and seated in the drive motor lumen when the

CA 02256132 1998-12-169135400.APP PATENT-11-brush sub-assembly connector and the drive motor unitconnector are engaged as described above. The brush can be retracted proximally into the brushdrive shaft lumen when the proximal drive member is notreceived and seated in the drive motor lumen. The brush canthereby be garaged therein to facilitate introduction of thebrush sub-assembly to a site of a soft obstruction. Thebrush drive shaft can also be manually advanced distally inthe same path to distally extend the brush out of thecatheter lumen distal end opening. In accordance with afurther aspect of the invention, the brush and a distalportion of the brush drive shaft distal section areautomatically extended out of the catheter lumen distal endopening when the drive member is received in and seated inthe drive motor lumen upon engagement of the brush sub-assembly connector with the drive motor unit connector. In the practice of the preferred embodiment, aguidewire is advanced to the site of a thrombus in a bloodvessel lumen or the lumen of a medical implant. Theproximal end of the guidewire is inserted into the driveshaft lumen distal end opening, and the drive shaft anddelivery catheter are advanced over the guidewire to thesite. While the over-the-wire advancement can be performedwith the brush sub-assembly coupled with the drive motorunit, doing so requires that the brush be extended from thedelivery catheter lumen distal end opening. It is preferredthat the brush be garaged within a distal end section of thebrush delivery catheter lumen during the advancement to thesite. After the brush is advanced to the site, the proximalend of the guidewire is inserted into the drive motor unitlumen distal end opening, and the drive motor unit is

CA 02256132 1998-12-169135400.APP PATENT-12-advanced distally over the wire until the proximal end ofthe guidewire extends proximally from the drive motor unitlumen proximal end opening. Then, the proximal drive member is axially aligned withand inserted axially into the distal drive motor lumenopening and seated therein, engaging the drive hub with thedrive chuck and sealing the proximal drive motor lumenopening from the back flow of blood through the drive shaftlumen. The sub-assembly connector and the drive motor unitconnector positively lock together upon axial insertion andmutual engagement of the connectors. The mutual engagementof the connectors allows rotation of the brush sub-assemblywith respect to the drive motor unit to a selected angularalignment. The mutual engagement of the connectors allowsthe proximal drive member to be rotated by the drive motorunit at any selected angular alignment of the brush sub-assembly with respect to the drive motor unit. In this manner, the brush is advanced out of the brushdelivery catheter lumen and positioned in relation to anelongated soft obstruction. The drive shaft is rotated byenergizing the drive motor in a prescribed rotationdirection, and the brush is retracted proximally through thesoft obstruction. A thrombolytic agent is delivered from aside port of a Y-connector and through the brush deliverycatheter lumen alongside the drive shaft and out of thedelivery catheter distal end opening adjacent to the brush. The fibrin of the soft obstruction is macerated by therotating brush bristles into particles or otherwise exposedas the thrombolytic agent is delivered. The guidewire can also be withdrawn proximally and re-inserted and advanced distally through the drive shaft lumenif necessary. The guidewire can also be inserted into and

CA 02256132 1998-12-169135400.APP PATENT-13-extended distally through the drive motor unit lumen fromthe drive motor lumen distal end opening when the brush sub-assembly is not attached. The attachment mechanism of thepresent invention allows this to take place without anydanger that the guidewire will be damaged by effecting theattachment. The attachment mechanism of the present invention canbe effected at any angular orientation of the brush sub-assembly to the drive motor unit with or without a guidewireor microcatheter inserted through the drive shaft lumen. Then, the orientation can be adjusted by a free rotation ofthe drive motor unit without disturbing the attachmentitself, unlike the use of a threaded or luer lock attachmentmechanism. This avoids having to hold the brush sub-assembly and any guidewire or microcatheter steady while thedrive motor unit is rotated to complete the attachment. In this way, the present invention also advantageouslyallows the side port of the Y-connector and the tubingattached to it to be rotated to an angle that allows freedomof manipulation of the drive motor unit without tangling thetubing or imposing any load on the drive shaft and anyguidewire or microcatheter inserted through the drive shaftlumen. While the invention is preferably realized in thepreferred embodiments for coupling a brush sub-assembly witha drive motor unit, it can also be employed in coupling anobstruction treatment sub-assembly with a drive motor unit. This summary of the invention and the objects,advantages and features thereof have been presented heresimply to point out some of the ways that the inventionovercomes difficulties presented in the prior art and todistinguish the invention from the prior art and is notintended to operate in any manner as a limitation on the

CA 02256132 1998-12-169135400.APP PATENT-14-. interpretation of claims that are presented initially in thepatent application and that are ultimately granted. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects, advantages and features of theinvention will become apparent from the following detaileddescription of the preferred embodiments of the invention,in which: FIG. 1 is a plan view of a first preferred embodimentof the motor and brush assembly of the present invention; FIG. 2 is an enlarged, plan view of the brush sub-assembly depicting the clip connector of a first embodimentof the invention; FIG. 3 is a cross-section view of the clip connector ofthe first embodiment of the invention and an attached Y-connector taken along lines 3-3 of FIG. 2; FIG. 4 is an exploded view of components of the drivemotor unit of FIG. 1; FIG. 5 is a distal end view of the drive motor unit of FIG. 1; FIG. 6 is a proximal end view of the drive motor unitof FIG. l; FIG. 7 is a side partial cross-section view of-thedrive motor unit of FIG. 1 depicting the arrangement forreceiving the brush drive shaft proximal end and forattachment with the clip connector of the brush sub-assembly; FIG. 8 is an exploded, enlarged, perspective view ofthe components of the dynamic rear seal that fits in thedrive motor lumen and seals the interior components of thedrive motor unit from blood that backflows through the driveshaft lumen during use of the motor and brush assembly;

CA 02256132 1998-12-169135400.APP PATENT-15- FIG. 9 is an end-to-end plan view of the alignment ofthe brush drive shaft proximal end and a guidewire proximalend prior to their insertion into the drive motor lumendistal end opening; FIG. 10 is a side partial cross-section view of thedrive motor unit depicting the insertion of the proximal endof the guidewire into the drive motor lumen distal endopening and its distal advancement through the drive motorlumen to exit its proximal end opening; FIG. 11 depicts the partial advancement of the brushshaft proximal end into the drive motor lumen over theguidewire and the separation of the clip free ends of theclip connector as they ride upon the cam surface of thedrive motor housing; FIG. 12 is a side partial cross-section view of thedrive motor unit depicting the advancement of the brushshaft proximal end into the drive motor lumen over theguidewire to the fully seated position and the engagement ofthe clips into the groove encircling the nose of the drivemotor housing; FIG 13 is a distal end view of the drive motor unit andthe clip connector taken along lines 13-13 of FIG 12 and therotation thereof to a further angular orientation of thebrush sub-assembly with the drive motor unit; FIGS. 14 and 15 depict the insertion into the proximalend opening and distal advancement of a guidewire throughthe rear seal and a guide in the drive motor lumen thatfacilitates replacement of guidewires; FIG. 16 is a distal end view of a further embodiment ofa clip connector that is attached to the drive motor unithousing and operated to engage and disengage with theproximal end of the brush sub-assembly;

CA 02256132 1998-12-169135400.APP PATENT-16- FIG. 17 is a side partial cross-section view takenalong lines 17-17 of FIG. 16 of the clip connector of FIG.16 in an open position for receiving or releasing and aclosed position for engaging the proximal end of the brushsub-assembly; and FIG. 18 is an exploded view of the componentsillustrated in FIG. 17 in relation with the proximal end ofthe brush sub-assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION In view of the apparent interchangeable use in thebackground art, only the terms "soft obstruction" or"thrombus" and "thrombectomy" will be employed in thefollowing description of the preferred embodiments of theinvention, and it will be understood that these terms shallembrace and be the equivalent of blood clot or embolus andembolectomy, respectively, and are applicable to the removalof soft, recently formed thrombi or blood clots. FIG. 1 illustrates a motor and brush assembly 10 whichincorporates one embodiment of a simplified, repeatable,precise and positive attachment mechanism of a firstpreferred embodiment for attaching a brush sub-assembly 100with a drive motor unit 200. A further preferred embodimentof the attachment mechanism is depicted in FIGS. 16-18. These attachment mechanisms allow full 360° rotation of thebrush sub-assembly 100 with respect to the drive motor unit200. In addition, these attachment mechanisms preciselyaxially align and engage a hollow brush drive shaft of thebrush sub-assembly with drive and sealing components of thedrive motor unit 200 for rotation of the drive shaft andattached distal brush.

CA 02256132 1998-12-169135400.APP PATENT-17-_ The brush sub-assembly 100, including the brush driveshaft 20, the brush delivery catheter 30, a clip connector70 and a Y-connector 50 is also depicted separately in FIG.2 and in FIG. 3 in part. The brush drive shaft 20 extendsfrom its proximal end 23 to its distal end 21 through theclip connector lumen 80 of clip connector 70, the Y-connector lumen 68 of Y-connector 50 and the deliverycatheter lumen 32 of delivery catheter 30. The drive shaft20 is formed of a number of sections that are attachedtogether in tandem and provide a continuous drive shaftlumen 28. The continuous drive shaft lumen 28 extends allthe way from the drive shaft lumen proximal end opening atthe proximal drive shaft end 23 to the drive shaft lumendistal end opening at distal drive shaft end 21 in which themicrocatheter or guidewire 40 can be received. The driveshaft sections include a relatively long flexible, distaldrive shaft section 24, a relatively short and stiff,intermediate drive shaft section 25, and a furtherrelatively short and stiff, proximal drive shaft section 27. The distal drive shaft section 24 is preferably formedof thin wall tube having a 1.4 mm O.D. and a 1.0 mm driveshaft lumen I.D., the thin wall tube formed of polyetheramide coated over stainless steel wire braid. A distaldrive shaft portion 22 of the distal drive shaft section 24extends outward of the distal end opening of the brushdelivery catheter 30 when the brush sub-assembly 100 isattached to the drive motor unit 200 as shown in FIG. 1. The brush 26 is formed around the periphery of the distaldrive shaft portion 22 that can be retracted into the brushdelivery catheter lumen 32 when the brush sub-assembly 100is not attached to the drive motor unit 200 in a mannerdescribed below. The brush bristles may take the form of

CA 02256132 1998-12-169135400.APP PATENT' -18-those described in the above-incorporated '653 or '355patents or the embodiments disclosed in the above-referenced'(9135390.APP) application. The intermediate drive shaft section 25 is preferablyformed of a hypotube, e.g., a stainless steel tube, that iscoated with polytetrafluoroethylene (PTFE) and has a tube O.D. and tube lumen I.D. dimensioned to receive the proximalend of the relatively flexible distal drive shaft section24. An enlarged, annular, distal stop 44 is formed at thejunction of the proximal end of the distal drive shaftsection 24 and the distal end of the intermediate driveshaft section 25 as shown in FIGs. 2 and 3. Theintermediate drive shaft section extends proximally throughthe Y-connector lumen 68 and then through the clip connectorlumen 72 and extends proximally therefrom a furtherpredetermined distance to its proximal end within a drivehub 90. An enlarged, annular, proximal stop 46 is formed ata predetermined point along the length of the intermediatedrive shaft section 25. The proximal drive shaft section 27 is also preferablyformed of a hypotube, e.g., a stainless steel tube, that iscoated with PTFE that has a tube O.D. and tube lumen I.D.similar to those of the distal drive shaft section 24. Thedistal end of the proximal drive shaft section 27 isinserted into the tube lumen of the intermediate drive shaftsection, and the drive hub 90 is formed over the junction ofthe proximal and intermediate drive shaft sections. Theproximal drive shaft section 27 extends from that junction apredetermined distance to the proximal drive shaft end 23. In FIG. 2, the proximal drive shaft section 27 and adistal portion of the intermediate drive shaft sectionextending to the proximal stop 46 constitute a proximal

CA 02256132 1998-12-169135400.APP PATENT- -19-drive portion 29 of the drive shaft 20. In FIG. 1, theproximal drive portion 29 extends through the schematicallyillustrated drive motor lumen 210 of the drive motor unit200 with the proximal drive shaft end 23 seated within sealassembly 220. The dimensions between the proximal driveshaft end 23 and the drive hub 90 and the proximal stop 46are selected to match the overall length of the drive motorlumen 210 drive components engaging the drive hub 90 asdescribed below. The drive hub 90, shown in FIG. 2, isdimensioned and formed about the proximal drive shaftsection 24 and spaced distally from proximal drive shaft end23 sufficiently to be engaged in a drive chuck along thedrive motor lumen 210 when the proximal drive shaft end 23is seated as shown in FIG. 1. The drive hub 90 is formed ofan elongated distal cylinder 92 surrounding the drive shaftsurface and an elongated proximal, square cross section bar94 molded as a single piece over the junction of the distaland proximal ends of the proximal and intermediate driveshaft sections 27 and 25, respectively. The drive shaft 20 is trapped within the aligned brushdelivery catheter lumen 32, Y-connector lumen 68 and clipconnector lumen 80 so that it cannot be removed therefrom. The distal and proximal stops 44 and 46, respectively, arelocated a precise distance apart from one another and fromthe drive hub 90 and proximal drive shaft end 23 along theintermediate drive shaft section 25. The distal stop 44fits within the Y-connector lumen 68, and the proximal stop46 is located proximal to the proximal annular seat 82 andis greater in diameter than the clip connector lumen 80. The stops 44 and 46 allow the drive shaft 20 to be advanceddistally within the aligned lumens 32, 68 and 80 until thedistal stop 46 engages against the proximal surface of the

CA 02256132 1998-12-169135400.APP PATENT-2 0-proximal annular seat 82 and advanced proximally until thedistal stop 44 engages against a narrowed proximal end ofthe Y-connector lumen. A limited longitudinal travelsufficient to allow the brush 26 to be retracted proximallyin the direction of arrows 96 and 98 of FIG. 1 and garagedwithin a distal section of the of the brush deliverycatheter lumen 32 is thereby provided. The brush sub-assembly 100 further includes the brushdelivery catheter 30 having a catheter lumen 32 forreceiving the distal drive shaft section 24 including thedistal drive shaft portion upon which the brush 26 isformed. The brush delivery catheter 30 is reinforced by areinforcing tube 34 for providing stress relief extendingdistally a short distance from its proximal end 36. Thereinforced proximal end 36 of the brush delivery catheter 30is attached to the threaded distal end 60 of a Y-connector50 through use of a threaded compression cap 48 as shown in FIG. 3. In this way, the brush delivery catheter lumen 32is aligned with the Y-connector lumen 68. The brushdelivery catheter 30 preferably may be about 65 cm to about115 cm long, and have a 6 French (2.06 mm) O.D. and a lumen I.D. of about 1.73 mm. The brush delivery catheter 30preferably is formed of a tubular wire braid that is, encasedin a plastic material and is relatively flexible. The brushdelivery catheter distal end 38 preferably has a radiopaquering or band formed around the distal end opening of thebrush delivery catheter lumen 32. A side port extension 62 of Y-connector 50 provides afluid coupling with the brush delivery catheter lumen 32 viathe Y-connector lumen 68 and the side port lumen 54. Aflexible extension tube 64 extends from the side port

CA 02256132 1998-12-169135400.APP PATENT-21-extension 62 and terminates in an infusion port 66 forattachment to a source of thrombolytic agent (not shown). The clip connector 70 constitutes one preferredembodiment of a brush sub-assembly connector and is coupledby a threaded distal coupling 84 to the threaded proximalend 56 of the Y-connector 50. A clip connector barrel 71surrounds a constant diameter clip connector lumen 80 thatis thereby aligned with the Y-connector lumen 68. An O-ring52 is trapped in an annular recess within the lumen 68 atthe threaded proximal end 56. The O-ring lumen tightlyreceives and bears against the intermediate brush driveshaft section 25 extending through the lumens 68 and 80. The clip connector lumen 80 extends to the proximal endopening thereof within an enlarged proximal annular seat 82. The threaded female couplings 48 and 84 are tightly screwedonto the threaded male ends 60 and 56, respectively, andadhesive may be applied to assure that the attachedcomponents cannot loosen and rotate. The clip connector 70 further comprises a pair ofmoment arms 76 and 78 joined by hinges 73 and 75,respectively, disposed at 180° apart positions on thecircumference of the clip connector barrel 71 and extendingproximally to either side of the proximal annular seat 82. The free clip ends 77 and 79 of the moment arms 76 and 78,respectively are turned inward extending radially toward oneanother and the axis of the connector barrel 71 to formattachment clips. The free clip ends 77 and 79 are biasedby the hinges 73 and 75 to have a pre-determined separationapart from one another. The moment arms 76 and 78 alsoextend distally from hinges 73 and 75, respectively, tofinger grips 72 and 74, respectively. The hinges 73 and 75are resilient enough to allow finger grips 72 and 74 to be

CA 02256132 1998-12-169135400.APP PATENT' -22-squeezed together toward the barrel 71 to increase theseparation of the free clip ends 77 and 79, respectively. The interaction of the free clip ends 76 and 78 with acircular retention groove 240 of drive motor unit 200 allowsthe attachment of the brush sub-assembly 100 with the drivemotor unit 200 as described below. A guidewire 40 is shown in FIGS. 1 and 2 extending fromthe distal and proximal end openings of the distal andproximal ends 21 and 23 of the drive shaft lumen 28. In FIG.1, the guidewire 40 is depicted exiting the proximal endopening of the drive motor lumen 210. It will be understoodthat the guidewire 40 is provided for over-the-wireintroduction and positioning of the distal end of the brushsub-assembly 100 in relation to a soft obstruction in ablood vessel or a vascular access device or the like. Theguidewire 40 may be withdrawn during rotation of the brush26, or may be left in place as described below. Returning to the drive motor unit 200 shown in FIG. l,it includes a battery powered drive motor, gear assembly,and a drive chuck aligned with the drive motor lumen 210 ofthe drive motor unit 200. The drive motor lumen 210 isschematically depicted extending in alignment with the Y-connector lumen 68 and the clip connector lumen 80.- Thedrive motor lumen 210 terminates proximally with theproximal seal assembly 220 (shown in partial cross-section)that seals the interior of drive motor unit 200 from bloodescaping from the proximal end opening of the drive shaftlumen 28.It will be understood that drive motor unit 200 onlyrotates the hollow lumen drive shaft 20 and the brush 26formed about distal drive shaft section 22. The internaldrive motor is turned on by depression of push-button switch

CA 02256132 1998-12-169135400.APP PATENT-23-230 which closes and provides battery power to the internaldrive motor. In a thrombectomy application, the internaldrive motor rotates the drive shaft 20 relatively slowly, onthe order of about 500 - 3000 RPM and in a single direction. As noted above, a thrombolytic agent is delivered intothe space in Y-connector lumen 68 outside of the outersurface of the proximal drive shaft section 24 shown in FIG.3. The trapped 0-ring 52 within compression cap 84 providesa rotary seal within the proximal end of the Y-connector 50for sealing around the exterior surface of the proximaldrive shaft section 24. The compressed 0-ring 52 inhibitsthe back flow of thrombolytic agent or blood through theclip connector lumen 80 and into the drive motor lumen 210. The thrombolytic agent is forced distally through theannular space between the outer surface of the proximaldrive shaft section 24 and the inner surface of the brushdelivery catheter 30 until it escapes from the annularopening at the brush delivery catheter distal end 38. The rotation of the brush 26 to separate and mix thefibrin of a soft obstruction while a thrombolytic agent issupplied to it generally follows the teachings of the above-incorporated '653 patent. The attachment mechanisms, theproximal seal assembly 220, and other features of the drivemotor unit 200 of the present invention are not disclosed inthe above-incorporated '653 and '355 patents or employed inthe earlier above-referenced Cragg Thrombolytic BrushT""system. FIGS. 4-8 depict the components and construction of thedrive motor unit 200 in greater detail. The drive motorunit 200 is formed with a proximal housing section 202 and adistal housing section 204 that are molded of plasticmaterial and adhered together at an overlapping seam 206.

CA 02256132 1998-12-169135400.APP PATENT- -24- The proximal housing section 202 is formed with a receptacle208 and pin 212 for receiving an integral battery and DCdrive motor 214. The battery and drive motor 214 arecoupled electrically to a switch button 230 in housing halfsection 204 which applies battery power to the drive motorto rotate the drive shaft 262 and the drive gear 264attached to it. The teeth of the drive gear 264 mesh with teeth of adriven gear 274 which is formed integrally with a chuck body270 for receiving the drive shaft hub 90. The integralchuck and driven gear unit 290 is supported to be in axialalignment with and define part of the drive motor lumen 210. The drive motor lumen 210 extends between the proximal lumenend opening 248 and the distal lumen end opening 246. Firstand second proximal lumen cylindrical bores 250 and 252extend distally from the proximal drive motor lumen endopening 248 to a conical guide 252 that surrounds a bore 256through the end of the first cylindrical bore 250. Thesecond cylindrical bore 252 houses the components of thedynamic seal 220. The dynamic seal 220 is also shown in the end view of FIG. 6 and the perspective view of FIG. 8. The dynamic sealand is formed of a rigid plastic proximal cylindrical guidemember 222, a rigid plastic distal cylindrical guide member226 and a soft silicone rubber annular O-ring 224. Theproximal guide member 222 has an axial bore 236 extendingthrough it from a conical or funnel shaped, proximal guide228 formed in its proximal surface to an annular seat 234formed in its distal surface. The distal guide member 226has a funnel or conical shaped, distal guide 232 formed inits distal surface. The 0-ring 224 is trapped betweenmembers 222 and 226 in the seat 224 and it forms a sealing

CA 02256132 1998-12-169135400. APP ~ PATENT-25-orifice that bears against the outer surface of drive shaftproximal section 24 when it is inserted through it and itsproximal end 23 seated proximally to the location of the 0-ring 224. The dynamic seal 220 is axially inserted into thesecond bore 252 until it abuts the distal end thereof and issealed in place. The integral chuck and driven gear unit 290 issupported to be in alignment with and define part of thedrive motor lumen 210 by cooperation with a distal supporttube 205 (shown in FIG. 7) and a proximal support tube 260. The distal support tube 205 is formed integrally with thedistal housing section 204 and extends proximally thereinand in axial alignment with the drive motor lumen 210 anddistal drive motor lumen end opening 246. The free end 207of the distal support tube 205 provides a bearing surfacefor engagement against an annular distal shoulder 271 of theintegral chuck and driven gear unit 290. A distal end ofthe proximal support tube 260 is pressed into the bore 278of the proximal axis extension 276 of the integral chuck anddriven gear unit 290. The proximal end of the support tube260 bears against an annular seat 258 surrounding the bore256. The lumen diameter of the support tube 260 is sized toallow passage of the brush drive shaft proximal section 24therethrough. When the components of FIG. 4 are fittedtogether in the manner shown in FIG. 7, the drive motorlumen 210 is formed, and the teeth of the drive gear 264mesh with the teeth of the driven gear 274. The integral chuck and driven gear unit 290 alsocomprises the expandable drive chuck 280 which is formed offour 90° section chuck elements that together encircle acircular bore 288. Two of the chuck elements 282 and 284are depicted in the cross-section view. The four chuck

CA 02256132 1998-12-169135400.APP PATENT- -2 6-elements are attached at their proximal ends to the chuckbody 270 and extend distally to free ends that are taperedto form a conical distal entrance into the circular chuckbore 288. The proximal end of the circular bore 288 isaligned with the square chuck bore 286. The circular andsquare chuck bores are dimensioned to receive the cylinder92 and bar 94, respectively, of the drive hub 90. The fourchuck elements spread apart at their free ends within thebore of tube 205 as the hemispheric ends of the cylinder 92are pushed against them proximally during insertion and orpulled against them distally during retraction as shown in FIG. 11. In the first preferred embodiment of the drive motorunit connector 239, the drive motor unit housing 204 isformed with an annular, dome shaped cam surface 242surrounding the drive motor unit distal end opening 246 asshown also in FIG. 5. The cam surface 242 increases indiameter radially outward from the axis of the drive motorunit lumen 210. The cam surface 242 is maximally bounded byan annular retention groove 240 recessed into the drivemotor unit housing. An annular, proximally extending, drivemotor unit receptacle 244 is formed within the dome shapedprojection that also surrounds the drive motor unit-distalend opening 246. The annular retention groove 240surrounding the annular receptacle 244, the annularreceptacle 244, and the cam surface 242 extendingtherebetween comprise the drive motor unit connector 239. FIG. 9 is an end-to-end plan view of the alignment ofthe brush proximal drive shaft end 23 and a guidewireproximal end 41 prior to their insertion into the distaldrive motor lumen end opening 246. FIG. 9 also depicts thedimensional relation between the components of the proximal

CA 02256132 1998-12-169135400.APP PATENT' -27-drive portion 29 and the mating components of the sub-assembly connector 70 and along the drive motor lumen 2I0. The proximal drive portion 29 is defined by the portion ofthe proximal drive shaft section 24 that is proximal to andincludes the proximal stop 46. All of the proximal driveportion 29 is adapted to be received within the drive motorunit lumen 210. In FIG. 9, the distal stop 44 is depicted withdrawnproximally against the proximal annular seat 82 in contrastto the position depicted in FIG. 2. This withdrawal iseffected manually. The brush 26 and distal drive shaftsection 22 are retracted into the brush delivery catheterlumen 32 to facilitate advancement of the brush sub-assembly100 over the guidewire 40 to the site of the softobstruction. The brush bristles of brush 26 are preferablyformed as described in the above-referenced '(9135390. APP)application. The brush bristles are folded down "with thegrain" against the distal drive shaft section 22 and thesurrounding inner wall of catheter lumen 32 and extenddistally as they are garaged therein. FIG. 10 is a side partial cross-section view of thedrive motor unit 200 depicting the insertion of theguidewire proximal end 41 into the distal drive motor lumenend opening 246 and its distal advancement through the drivemotor lumen 210 to exit its proximal end opening 248. Theconical guide surfaces of the expandable chuck 280 and theguide funnel 232 direct and guide the proximal advancementof the guidewire proximal end 41 through the drive motorlumen 210. The brush sub-assembly 100 and the drive motorunit 200 are then positioned to be brought together byattachment of the sub-assembly connector 70 with the drivemotor unit connector 239.

CA 02256132 1998-12-169135400.APP PATENT-28- FIG. 11 depicts the partial proximal advancement of thebrush shaft proximal drive portion 29 into the drive motorlumen 210 over the guidewire 40. The clip ends 77 and 79 ofthe clips 76 and 78 ride upon and are separated apart by thecam surface 242. The proximal drive shaft end 23 approachthe 0-ring seal 224. The four chuck elements of drive chuck280 are spread apart at their free ends within the bore oftube 205 by the outer surface of the cylinder 92. The bar94 is already inserted partly into the square chuck bore286. FIG. 12 is a side partial cross-section view of thedrive motor unit 200 depicting the full advancement of theproximal drive portion 29 into the drive motor lumen 210over the guidewire 40 to the fully seated position. Theclip ends 77 and 79 are dropped into the retention groove240. FIG 13 is a distal end view of the drive motor unit200 and the clip connector 70 taken along lines 13-13 of FIG12. FIG. 13 depicts the rotation of the clip connector 70to a further angular orientation of the brush sub-assembly100 with respect the drive motor unit 200. The attachment of the brush sub-assembly connector 70with the drive motor unit connector 239 is thus effected byaxially aligning the proximal seat 82 with the annularreceptacle 244 and pressing the free clip ends 77 and 79against the cam surface 242 to cause the free clip ends 77and 79 to ride upon the cam surface 242 and to separateapart. The separation continues until the free clip ends 77and 79 slip into the retention groove 240 and lock therein. The clip connector 70, the Y-connector 50 and the drugdelivery catheter 30 can be rotated manually through 360°around the brush drive shaft 20 and the guidewire 40 as the

CA 02256132 1998-12-169135400.APP PATENT-2 9-free clip ends 77 and 79 slip along and within the retentiongroove 240. The detachment of the free clip ends 77 and 79 from theretention groove 240 for removing the brush sub-assembly 100from the drive motor unit 200 is effected by depressing thefinger grips 72 and 74 toward one another and drawing thedrive motor unit 200 and brush sub-assembly apart. Thehinges 73 and 75 (FIG. 3) allow the finger grips 72 and 74to be squeezed together toward the connector barrel 71 whichincreases the separation of the free clip ends 77 and 79until they are released from the retention groove 240. Summarizing the use of the motor and brush assembly 10in a thrombolytic procedure, a percutaneous access isprovided into an occluded medical implant lumen or intovasculature leading to an occluded native blood vessel orvascular implant in a conventional manner as disclosed inthe above-incorporated '653 patent and Cragg Thrombolytic BrushT"" literature, for example. The guidewire 40 isadvanced through the access device and the vasculature ordirectly into the accessed medical implant until its distalend passes through the soft obstruction in the lumenthereof. The guidewire proximal end 41 extends proximallyfrom the vasculature access device extending through theskin. Then, it is possible to advance the brush sub-assembly 100 over the guidewire 40 while the distal brush 26is garaged within the distal section of the brush deliverycatheter lumen 32 as described above with respect to FIG. 9. The advancement of the distal ends of the brush deliverycatheter 30 and the drive shaft 20 can be monitored byobserving the distal end radiopaque markers usingfluoroscopy. When the site of the soft obstruction isreached, advancement over the guidewire 40 is halted.

CA 02256132 1998-12-169135400.APP PATENT-30- Typically, the brush sub-assembly is advanced over theguidewire until it is disposed distally of the softobstruction so that it can be treated as described below insections as the brush sub-assembly is retracted proximallythrough it. After the soft obstruction is reached, the guidewireproximal end 41 is inserted into the distal drive motorlumen end opening 246 as described with reference to FIGS. 9and 10 until the guidewire distal end 43 of the guidewire 40extends proximally from the proximal seal assembly 220. Atthis point, the proximal drive shaft end 23 is inserted intothe distal drive motor lumen end opening 246 and advanced asdescribed with reference to FIGS. 11 and 12. During theapproach, the clips 76 and 78 spread apart as the respectiveclip free ends 77 and 79 bear against and then ride up onthe generally conical cam surface 242. When the clip freeends 77 and 79 snap into the annular retention groove 240, anumber of operations are completed and connections are made. Simultaneously, the proximal drive shaft end 23 is seatedinto the proximal seal assembly 220, the enlarged shaft hub90 is seated into the drive chuck receptacles 286 and 288,the brush 26 is advanced distally out of the distal sectionof the brush delivery catheter lumen 32, and the proximalstop 46 fits into the distal drive motor lumen end opening246. When assembly is complete as shown in FIG. 1, the brushsub-assembly 100 and the drive motor unit 200 can be rotatedwith respect to one another to orientations that facilitatethe infusion and manual manipulation of the assembly by thephysician as shown in FIG. 13. Then, the drive motor unitswitch 230 is closed to energize the drive motor. The brush26 is rotated through rotation of the drive shaft 20 by the

CA 02256132 1998-12-169135400.APP PATENT-31-proximal drive motor unit 200 in the prescribed rotationdirection for macerating the soft obstruction. At the sametime, a thrombolytic agent is applied through the sideextension 62 and through the brush delivery catheter lumen32 to the region of the brush 26. The rotation of the brushbristles causes the brush 26 to macerate the softobstruction and to impart a rotational velocity to thefragments. In such clinical use, the brush 26 is rotated ata speed and direction that effects a pumping action in theblood that maintains the soft obstruction fragments incontact with the delivered thrombolytic agent rather thanmoving the mixture distally away from the brush 26. The guidewire 40 can be left in place during rotationof the brush 26 or it can be retracted from the drive shaftlumen 28 and the proximal drive motor lumen end opening 248. The guidewire or a different guidewire, infusion wire, or aballoon or basket bearing guidewire or miniature cathetercan be advanced distally into the exposed drive shaft lumenproximal end opening and out of the distal end openingthereof. When the guidewire 40 or other elongated medical deviceis inserted through the drive shaft lumen 28, some amount ofblood and infused thrombolytic agent leaks back through itand escapes from the drive shaft lumen proximal end opening. The blood escapes proximally to the dynamic seal assembly220, and the dynamic seal assembly 220 prevents it frominfiltrating into the interior of the drive motor unit 200. Appreciably greater amounts of blood and infusedthrombolytic agent are emitted from the drive shaft lumenproximal end opening when the guidewire 40 is removed fromthe drive shaft lumen 28. In this case, the physician canstop the proximal drive motor lumen end opening 248 with a

CA 02256132 1998-12-169135400.APP PATENT-32-finger. Again, the blood pools in the opening proximally tothe dynamic seal assembly 220, and the dynamic seal assembly220 prevents it from infiltrating into the interior of thedrive motor unit 200. At times, it is also desirable to be able to advance aguidewire 40 or other elongated medical device distallythrough the drive motor lumen 210 when the proximal driveportion 29 is not seated therein. FIGS. 14 and 15 depictthe insertion of the guidewire distal end 43 into theproximal drive motor lumen end opening 248 and distaladvancement of a guidewire 40 through the dynamic rear seal220 and through distal conical guide 254 that facilitatessuch distal advancement of a guidewire 40. When assembly is complete as shown in FIG. l, the brushsub-assembly 100 and the drive motor unit 200 can be rotatedwith respect to one another to orientations that facilitatethe infusion and manual manipulation of the assembly by thephysician as shown in FIG. 13. Then, the drive motor unitswitch 230 is closed to energize the drive motor. The brush26 is rotated through rotation of the drive shaft 20 by theproximal drive motor unit 200 in the prescribed rotationdirection for macerating the soft obstruction. At the sametime, a thrombolytic agent is applied through the sideextension 62 and through the brush delivery catheter lumen32 to the region of the brush 26. The rotation of the brushbristles causes the brush 26 to macerate the softobstruction and to impart a rotational velocity to thefragments. In such clinical use, the brush 26 is rotated ata speed and direction that effects a pumping action in theblood that maintains the soft obstruction fragments incontact with the delivered thrombolytic agent rather thanmoving the mixture distally away from the brush 26.

CA 02256132 1998-12-169135400.APP PATENT-33-- The guidewire 40 can be left in place during rotationof the brush 26 or it can be retracted from the drive shaftlumen 28 and the drive motor lumen proximal end opening 248. The guidewire or a different guidewire, infusion wire, or aballoon or basket bearing guidewire or miniature cathetercan be advanced distally into the exposed proximal driveshaft lumen end opening and out of the distal end openingthereof. When the guidewire 40 or other such device is insertedthrough the drive shaft lumen 28, some amount of blood andinfused thrombolytic agent leaks back through it and escapesfrom the drive shaft lumen proximal end opening. The bloodescapes proximally to the dynamic seal assembly 220, and thedynamic seal assembly 220 prevents it from infiltrating intothe interior of the drive motor unit 200. Appreciablygreater amounts of blood and infused thrombolytic agent areemitted from the drive shaft lumen proximal end opening whenthe guidewire 40 is removed from the drive shaft lumen 28. In this case, the physician can stop the proximal drivemotor lumen opening 248 with a finger. Again, the bloodpools in the opening proximally to the dynamic seal assembly220, and the dynamic seal assembly 220 prevents it frominfiltrating into the interior of the drive motor u~iit 200. At times, it is also desirable to be able to advance aguidewire 40 distally through the drive motor lumen 210 whenthe proximal drive portion 91 is not seated therein. Forexample, during a medical thrombectomy procedure, aguidewire may be damaged and have to be replaced while thebrush is kept housed within the brush delivery catheterlumen. The brush sub-assembly 100 can be disconnected fromthe drive motor unit 200 and the guidewire distal end 43advanced through the drive shaft lumen 32, and the guidewire

CA 02256132 1998-12-169135400.APP PATENT- -34-proximal end 41 can be inserted into and advanced proximallythrough the drive motor lumen 210. Alternatively, theguidewire distal end 43 can be advanced first through thedrive motor lumen 210 and then through the drive shaft lumen32. In either case, the brush sub-assembly 100 and thedrive motor unit 200 can then be reattached afterreplacement and repositioning of the guidewire 40 to expelthe brush from the brush delivery catheter lumen. FIGS. 14and 15 depict the insertion into the drive motor lumenproximal end opening 248 and distal advancement of aguidewire 40 through the dynamic rear seal 220 and throughdistal conical guide 254 that facilitates such distaladvancement of a guidewire 40. A second embodiment of the mating connector assemblyfor allowing 360° rotation of the brush sub-assembly withrespect to the drive motor unit is depicted in FIGs. 16-18. In this embodiment, a clip connector 170 is attached to thedrive motor unit housing 204 and is operated to engage anddisengage with the annular distal attachment rim 182 of theproximal seat 82 of the brush sub-assembly 100. The brushsub-assembly 100 is only otherwise modified from that shownin FIGs. 1-15 by removal of the brush sub-assembly connector70. No retention groove is employed in housing section 204. The clip connector 170 further comprises a pair ofmoment arms 176 and 178 joined by hinges 173 and 175,respectively, to a circular clip connector ring 190 as aunitary structure. The moment arms are disposed at 180°apart positions on the circumference of the clip connectorbarrel 171 and extend proximally alongside and outwardly ofthe housing section 204. The free clip ends 177 and 179 ofthe moment arms 176 and 178, respectively are arcuate inshape. The free clip ends 177 and 179 extend inward toward

CA 02256132 1998-12-169135400.APP PATENT-35-the axis of distal drive motor lumen end opening 246sufficiently to rest against arcuate sections of theattachment rim 182. The arcuate free clip ends 177 and 179are biased by the hinges 173 and 175 to have a pre-y determined separation apart from one another whichcorresponds to the outer diameter of sub-assembly connectorbarrel 171. The moment arms 176 and 178 also extendproximally from hinges 173 and 175, respectively, to fingergrips 172 and 174, respectively. The hinges 173 and 175 areresilient enough to allow finger grips 172 and 1174 to besqueezed together toward the housing section 204 to increasethe separation of the arcuate free clip ends 177 and 179,respectively, as shown in the broken line position of FIG.17. The connector ring 190 is fitted into and adheredaround its outer wall to the annular receptacle 244. Aresilient O-ring 180 is fitted into the annular receptacle244 against the inner wall of connector ring 190 andretained there by inwardly extending arcuate clips 192 and194. The distance between the arcuate clips is greater thanthe outer diameter of the seat 82. The attachment of the brush sub-assembly connector 182with the drive motor unit connector 170 is effected=byaxially aligning the proximal face of seat 82 with the O-ring 180 in annular receptacle 244 and pressing it againstthe arcuate free clip ends 1?7 and 179. The slight radiusof the proximal face of seat 82 causes the free clip ends177 and 179 to separate apart. The separation continuesuntil the free clip ends 177 and 179 slip over the seat 82and against the distal rim 182 and lock against it. The seat82, the Y-connector 50 and the drug delivery catheter 30 canbe rotated manually through 360° around the brush drive

CA 02256132 1998-12-169135400.APP PATENT-36-shaft 20 and the guidewire 40 as the free clip ends 177 and179 slip along and around the distal rim 182. The detachment of the free clip ends 177 and 179 fromengagement against the distal rim 182 for removing the brushsub-assembly 100 from the drive motor unit 200 is effectedby depressing the finger grips 172 and 174 toward oneanother and drawing the drive motor unit 200 and brush sub-assembly apart. The hinges 173 and 175 allow the fingergrips 172 and 174 to be squeezed together toward the drivemotor housing section which increases the separation of thefree clip ends 177 and 179 until the distal rim 182 can bereleased. In any of the embodiments described above, theapparatus may be modified to allow infusate to be delivereddown the drive shaft lumen 26 as disclosed in certainembodiments of the above-incorporated '653 patent. Thedistal drive shaft section 22 may be pre-formed with weepholes or perforations to allow the dispersion of dissolvingagents or other fluids introduced down the lumen while theguidewire 40 is present or after it is withdrawn. The driveshaft lumen distal end opening may be provided with selfsealing flaps to seal about the guidewire 40 while the brushis advanced or to seal the lumen end opening after theguidewire 40 is retracted. This ensures that the introducedfluid is dispersed within or proximal to the brush bristles. The drive shaft lumen distal end opening may alternativelybe left open to provide a fluid dispersion or flushoperation distal to the brush 26. These and other featuresof and methods of use of the brush described in the above-incorporated '653 and '355 patents may be employed in theuse of the miniaturized brush of the present invention.

CA 02256132 1998-12-169135400.APP PATENT- -37- The miniaturized brush of the present invention providereduced overall outer diameter that enables its introductionthrough small diameter brush delivery catheter and/or bloodvessel lumens. In addition, the thin wall constructionprovides a drive shaft lumen 28 with a relatively enlargedinner diameter for introduction over a guidewire that may be0.035 inches in diameter, for example, and for introductionand passage of fluids therethrough. The drive shaft 20 ineach assembly is reinforced sufficiently to allowadvancement through tortuous blood vessel passageways and toprovide torque transfer to the distal brush 10, 10'. In the preferred embodiment of the invention, nofurther apparatus is employed or steps taken to dissolve thesoft obstruction or thrombus in situ. It is expected thatthe treatment will be commenced within hours of the onset ofdiagnosis, and the thrombus will be dissolved by thebrushing action continually exposing the fibrin of theobstruction to the dissolving agent. To the extent thatfragments are created, the agent should dissolve them beforethey are swept away by blood flow. In order to contain released fragments so that thedissolving agent may complete dissolution, the brush may beintroduced through the soft obstruction downstream androtated as the brush is slowly retracted through theobstruction. Optionally, a balloon catheter or a meshbasket may be coaxially introduced through the drive shaftlumen and placed downstream to temporarily obstruct theblood and dissolving agent flow away from the site andrestrain fragments to allow the concentrated dissolvingagent to complete the dissolution thereof. Advantageously, blood clots and thrombi are morereadily dissolved by the mixing action of the brush bristles

CA 02256132 1998-12-169135400.APP PATENT-38-as the dissolving agent is introduced. Intimal hyperplasiaand the risk of vessel wall rupture or pseudoneurism isdecreased by use of the soft brush bristles. The speed ofdissolution may be reduced to minutes, in comparison withhours for introduction of the dissolving agent alone. Thereduced amount of dissolving agent introduced decreases therisk of internal bleeding. Patient comfort is increased andcost of the intensive care treatment is reduced by theshortened time and reduction of exposure to the dissolvingagent. While the invention is preferably used in the abave-described medical procedures, it will be recognized that aminiaturized, hollow lumen brush may have other importantmedical applications. For example, the disclosed assemblymay be employed for specimen collection from various bodylumens including blood vessels and other vessels, openings,cavities or ducts, in the manner of a cytology brush. Moreover, while the present invention is described asparticularly usable and implemented in the above describedthrombolytic brush embodiments, it will be recognized thatit can also be employed in other motor driven catheterapplications employing other rotated obstruction treatmentdevices. For example, the obstruction treatment device ofthe following claims preferably constitutes the above-described flexible brush for macerating soft obstructions. However, the obstruction treatment device can take otherforms proposed for removing such soft obstructions or hardobstructions of a body vessel or vascular implant or otherlumen that are rotated by a drive motor unit. Suchobstruction treatment devices include expandable in situ orfixed diameter wire coils or baskets of the types shown, forexample, in U.S. Patent Nos. 4,646,736, 5,195,954 and

CA 02256132 1998-12-169135400.APP PATENT-39-5,330,484, incorporated herein by reference. Theobstruction treatment device can also take the form of acutting mechanism, e.g., an atherectomy cutting head of oneof the many known types, e.g. the cutting screw shown in U.S. Patent No. 5,423,799 or the expandable wires or bladesshown in U.S. Patent No. 5,030,201, both incorporated hereinby reference. Although the preferred embodiments of the inventiondescribed above are used with hollow drive shaft 20, it willbe understood that the same connector techniques can be usedto connect brush and obstruction treatment device sub-assemblies having solid core, rotatable drive shafts withdrive motor units. Although particular embodiments of the invention havebeen described herein in some detail, this has been done forthe purpose of providing a written description of theinvention in an enabling manner and to form a basis forestablishing equivalents to structure and method steps notspecifically described or listed. It is contemplated by theinventors that the scope of the limitations of the followingclaims encompasses the described embodiments and equivalentsthereto now known and coming into existence during the termof the patent. Thus, it is expected that various changes,alterations, or modifications may be made to the inventionas described herein without departing from the spirit andscope of the invention as defined by the appended claims.

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